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CompletedNCT00421993Updated Feb 18, 2021Results posted

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

A Phase 3 interventional study of Adapalene/Benzoyl Peroxide and Adapalene in Acne Vulgaris, sponsored by Galderma R&D. Completed at 62 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Galderma R&D · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,670
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • Acne vulgaris
  • Adapalene
  • Benzoyl Peroxide
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 1,670 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions
  • A minimum of 30 but not more than 100 Noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion criteria

Exclusion Criteria:

  • More than one acne nodule or any acne cyst.
  • Acne conglobata, acne fulminans, secondary acne, or severe acne.
  • Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
  • Underlying diseases that require the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period is documented
  • Use of hormonal contraceptives solely for control of acne
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,670 participants (actual)

Study arms

  • Experimental
    1

    Adapalene/Benzoyl Peroxide Topical Gel

    Drug: Adapalene/Benzoyl Peroxide

  • Active comparator
    2

    Adapalene Topical Gel

    Drug: Adapalene

  • Active comparator
    3

    Benzoyl Peroxide Topical Gel

    Drug: Benzoyl Peroxide

  • Placebo comparator
    4

    Topical Gel Vehicle

    Drug: Topical Gel Vehicle

Interventions

  • DrugAdapalene/Benzoyl Peroxide

    Topical Gel, One application daily in the evening for 12 weeks

  • DrugAdapalene

    Topical Gel,One application daily in the evening for 12 weeks

  • DrugBenzoyl Peroxide

    Topical Gel, one application daily in the evening for 12 weeks

  • DrugTopical Gel Vehicle

    Topical Gel Vehicle,one application daily in the evening for 12 weeks

06

What researchers measure

Primary outcomes

  1. Success Rate on the Investigator's Global Assessment

    Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)

    Time frame: at week 12

  2. Changes in Inflammatory Lesion Counts

    Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts

    Time frame: from Baseline to week 12

  3. Changes in Noninflammatory Lesion Counts

    Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

    Time frame: from Baseline to week 12

Secondary outcomes

  1. Percent Change in Inflammatory Lesion Counts

    Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

    Time frame: at week 12

  2. Percent Change in Noniflammatory Lesion Counts

    Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

    Time frame: at week 12

  3. Percent Change in Total Lesion Counts

    Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

    Time frame: at week 12

07

Results

Posted Mar 11, 2009

Participant flow

Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.

Participant flow — Overall Study
MilestoneAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Started419418415418
Completed366369363361
Not completed53495257
Withdrew: Withdrawal by subject22232324
Withdrew: Lost to follow-up18192220
Withdrew: Adverse event11164
Withdrew: Protocol violation2201
Withdrew: Lack of efficacy0305
Withdrew: Pregnancy0112
Withdrew: Subject transportation issues0001

Outcome measures

PrimarySuccess Rate on the Investigator's Global Assessment

Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)

Time frame:
at week 12
Reported as:
Number · Percentage of participants
Success Rate on the Investigator's Global Assessment
Percentage of participantsAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Success Rate on the Investigator's Global Assessment37.921.826.717.9
PrimaryChanges in Inflammatory Lesion Counts

Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts

Time frame:
from Baseline to week 12
Reported as:
Median · Lesion count
Changes in Inflammatory Lesion Counts
Lesion countAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Changes in Inflammatory Lesion Counts-18 (-49 to 50)-15 (-49 to 50)-16 (-63 to 38)-12 (-47 to 95)
PrimaryChanges in Noninflammatory Lesion Counts

Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

Time frame:
from Baseline to week 12
Reported as:
Median · Lesion count
Changes in Noninflammatory Lesion Counts
Lesion countAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Changes in Noninflammatory Lesion Counts-28 (-93 to 108)-24 (-96 to 44)-23 (-87 to 61)-18 (-82 to 69)
SecondaryPercent Change in Inflammatory Lesion Counts

Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame:
at week 12
Reported as:
Mean · Percent change
Percent Change in Inflammatory Lesion Counts
Percent changeAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Percent Change in Inflammatory Lesion Counts-61.7 ± 33.9-50.1 ± 39.4-52.2 ± 39.4-40.8 ± 41.1
SecondaryPercent Change in Noniflammatory Lesion Counts

Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame:
at week 12
Reported as:
Mean · Percent change
Percent Change in Noniflammatory Lesion Counts
Percent changeAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Percent Change in Noniflammatory Lesion Counts-55.6 ± 35.3-46.0 ± 33.7-44.1 ± 37.3-32.3 ± 39.5
SecondaryPercent Change in Total Lesion Counts

Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame:
at week 12
Reported as:
Mean · Percent change
Percent Change in Total Lesion Counts
Percent changeAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Percent Change in Total Lesion Counts-57.7 ± 31.9-47.5 ± 31.3-47.2 ± 32.7-35.2 ± 36

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adapalene/Benzoyl Peroxide Gel—3/419 (0.7%)90/419 (21.5%)
Adapalene Gel—1/418 (0.2%)60/418 (14.4%)
Benzoyl Peroxide Gel—1/415 (0.2%)35/415 (8.4%)
Gel Vehicle—2/418 (0.5%)22/418 (5.3%)
Most frequent serious events
Most frequent serious events
EventAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/4190/4181/4150/418
Abscess limbInfections and infestations0/4190/4180/4151/418
Cervical vertebral fractureInjury, poisoning and procedural complications0/4190/4180/4151/418
Schizoaffective disorderPsychiatric disorders0/4191/4180/4150/418
FuruncleInfections and infestations1/4190/4180/4150/418
AppendicitisInfections and infestations1/4190/4180/4150/418
ScoliosisMusculoskeletal and connective tissue disorders1/4190/4180/4150/418
Most frequent other events
Most frequent other events
EventAdapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel Vehicle
Dry SkinSkin and subcutaneous tissue disorders90/41960/41835/41522/418

Baseline characteristics

Age, Continuous
Age, Continuous(years)Adapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel VehicleTotal
Mean19.5 ± 6.718.5 ± 6.318.9 ± 6.9619.2 ± 7.2319 ± 6.81
Age, Customized
Age, Customized(participants)Adapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel VehicleTotal
12-17 years233241244243961
Between 18 and 64 years186177171175709
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)Adapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel VehicleTotal
Female236229230244939
Male183189185174731
Region of Enrollment
Region of Enrollment(participants)Adapalene/Benzoyl Peroxide GelAdapalene GelBenzoyl Peroxide GelGel VehicleTotal
United States185185179185734
Canada102100100101403
Europe132133136132533
08

Study locations

62 sites
  • Medical Affliated Research Center
    Huntsville, Alabama 35801, United States
  • Dermatology Research of Arkansas
    Little Rock, Arkansas 72205, United States
  • Associates in research, Inc.
    Fresno, California 93720, United States
  • University of California, Irvine
    Irvine, California 92697-1385, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
    Marina Del Rey, California 90292, United States
  • Affiliated Research Institute
    San Diego, California 92108, United States
  • University at San Francisco Medical Center
    San Francisco, California 94143, United States
  • Radiant Research
    Santa Rosa, California 95405, United States
  • Dr Weintraub James
    Simi Valley, California 93065, United States
  • The George Washington University Medical Center
    Washington, District of Columbia 20037, United States
  • Visions Clinical Research
    West Palm Beach, Florida 33406, United States
  • Atlanta Dermatology and Vein Research Center
    Alpharetta, Georgia 30005, United States
  • SKINQRI
    Lincolnshire, Illinois 60069, United States
  • Welborn Clinic
    Evansville, Indiana 47713, United States
  • Dawes Fretzin Clinical Research Group, LLC
    Indianapolis, Indiana 46256, United States
  • Dolby Research, LLC
    Baton Rouge, Louisiana 70809, United States
  • Hamzavi Dermatology
    Port Huron, Michigan 48060, United States
  • Somerset Skin Clinic
    Troy, Michigan 48084, United States
  • James Del Rosso, DO - Office of Dr. James Del Russo
    Henderson, Nevada 89052, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Skin Specialty Group
    New York, New York 10021, United States
  • Derm Research Center of NY, Inc.
    Stony Brook, New York 11790-2598, United States
  • Zoe Draelos
    High Point, North Carolina 27262, United States
  • OU Health Sciences Center - Dept. of Dermatology
    Oklahoma City, Oklahoma 73104, United States
  • Allergy, Asthma and Dermatology Research Center, LLC
    Lake Oswego, Oregon 97035, United States
  • Radiant Research
    Anderson, South Carolina 29621, United States
  • Dermatology Associates of Knoxville
    Knoxville, Tennessee 37934, United States
  • Arlington Center for Dermatology
    Arlington, Texas 76011, United States
  • UTSW Medical Center at Dallas
    Dallas, Texas 75390-9190, United States
  • University of Texas Medical Branch at Galveston
    Galveston, Texas 77555, United States
  • Tanner Clinic
    Layton, Utah 84041, United States
  • Fletcher Allen Health Care
    Burlington, Vermont 05401, United States
  • The Dermatology Centre
    Calgary, Alberta T2S 3B3, Canada
  • Stratica Medical
    Edmonton, Alberta T5K 1X3, Canada
  • Guildford Dermatology Specialists
    Surrey, British Columbia BC V3R 6A7, Canada
  • Derm Research @ 888 Inc.
    Vancouver, British Columbia V5Z 3Y1, Canada
  • Winnipeg Clinic
    Winnipeg, Manitoba R3C 0N2, Canada
  • Dermadvances Research
    Winnipeg, Manitoba R3C 1R4, Canada
  • Nexus clinical research
    St. John's, Newfoundland and Labrador A1B 3E1, Canada
  • NewLab Clinical Research
    St. John's, Newfoundland and Labrador A1B 4S8, Canada
  • Ultranova Skin care
    Barrie, Ontario L4M 6L2, Canada
  • Lynderm Research inc.
    Markham, Ontario L3P 1A8, Canada
  • North Bay Dermatology Centre
    North Bay, Ontario P1B 3Z7, Canada
  • XLR8 Medical Research Inc.
    Windsor, Ontario N8W 1E6, Canada
  • Innovaderm Research Laval Inc.
    Laval, Quebec H7S 2C6, Canada
  • Innovaderm Research Inc
    Montreal, Quebec H2K 4L5, Canada
  • Siena Medical Research
    Montreal, Quebec H3G1C6, Canada
  • Licca Clinical Research Institute
    Augsburg, 86179, Germany
  • Henrik Pres
    Berlin, 10435, Germany
  • Meike Schroeder
    Berlin, 14169, Germany
  • Beatrice Gerlach
    Dresden, 01097, Germany
  • Kloverkorn, Windfried
    Gilching, 82205, Germany
  • Otto-Von-Guericke-Universitat Magdeburg
    Magdeburg, 39120, Germany
  • Michael Sebastian
    Mahlow, 15831, Germany
  • Thomas Dirschka
    Wuppertal, 42275, Germany
  • Outpatient Dermatology Department DUH
    Budapest, 1036, Hungary
  • Margit Simola
    Budapest, 1084, Hungary
  • Outpatient Dermatilogy Department XIX District
    Budapest, 1195, Hungary
  • Waldemar Placek
    Bydgoszcz, 85096, Poland
  • DERMED Specjalistyczne Gabinety Lekarskie
    Lodz, 90265, Poland
  • Wojceiech Silny
    Poznan, 60355, Poland
09

References and documents

Publications

  • Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x. PubMed 12963896 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00421993
Lead sponsor
Galderma R&D
First posted
Jan 15, 2007
Start date
Oct 2006
Primary completion
Oct 2007
Completion
Dec 2007
Results posted
Mar 11, 2009
Last update
Feb 18, 2021

Study contacts

Michael Graeber, MD
study director · Galderma R&D
View the source record on ClinicalTrials.gov ↗

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